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FDA 510(k)

SOFTEPIL

K-Number: K843735 · 1984-10-25

ApplicantNemectron Medical, Inc.
Decision Date1984-10-25
Product CodeKCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTEPIL is the device name listed in this FDA 510(k) record. The listed applicant is Nemectron Medical, Inc.. It received FDA 510(k) clearance on 1984-10-25 under 510(k) number K843735. The device is classified under product code KCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTEPIL?

SOFTEPIL is a medical device that received FDA 510(k) clearance on 1984-10-25. The listed applicant is Nemectron Medical, Inc.. The 510(k) number is K843735.

When did SOFTEPIL receive FDA 510(k) clearance?

SOFTEPIL received FDA 510(k) clearance on 1984-10-25, under 510(k) number K843735.

Who is the listed applicant for SOFTEPIL?

The FDA 510(k) record lists Nemectron Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFTEPIL?

The FDA product code for SOFTEPIL is KCX.

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Other records listing Nemectron Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K923396THERMODYNK895000NEMECTRON MICROWAVEK862376NEMECTROSON MODEL 2K854720NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM.K854721NEMECTRODYN MODEL 2 & ENDOVAC 2K844416THERMOPULS E

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Related Devices (Code: KCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973773DAPELLE HAIR REMOVERWellquest Intl., Inc.K973340TWEEZER-TYPE EPILATORMobit, Inc.K973179FEMINIQUE SONIC HAIR REMOVERGlobal TV Concepts, Ltd.K973174SONIQUE HAIR REMOVERGlobal TV Concepts, Ltd.K972695FINALLY FREEMehl/Group MarketingK970338TWEEZER-TYPE EPILATORIgia Direct, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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